FDA 510(k) Applications for Medical Device:
Antithrombin Iii Quantitation
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K974110 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92821-6208 |
| K952515 | CHROMOGENIX AB |
160 INDUSTRIAL DR. | FRANKLIN | OH | 45005 |
| K043007 | HYPHEN BIOMED |
6560 GOVE CT. | MASON | OH | 45040 |
| K022195 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K022550 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K070301 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K062431 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K033775 | INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD | BEDFORD | MA | 01730 |
| K980499 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K994238 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K000361 | KAMIYA BIOMEDICAL CO. |
910 INDUSTRY DR. | SEATTLE | WA | 98188-3412 |
| K960871 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
6025 NICOLLE ST. | VENTURA | CA | 93003 |
| K023991 | PRECISION BIOLOGIC |
900 WINDMILL RD., SUITE 100 | DARTMOUTH, N.S. | B3B 1P7 | |
| K242952 | Siemens Healthcare Diagnostic Products GmbH |
Emil-von-Behring Strasse 76 | Marburg | 35041 | |
| K081769 | SIEMENS HEALTHCARE DIAGNOSTICS |
500 GBC DRIVE M/S 514 | NEWARK | DE | 19702 |
| K972144 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
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